1. Field of the Invention
The present invention generally relates to compositions useful in relieving craving in a nicotine habituated patient who is abstaining from or reducing nicotine intake, and more particularly relates to edible compositions including an herbal component which provides multiple nicotine agonists, one of which is anabasine, but has little or no nicotine.
2. Description of the Related Art
Using 1996 data, the prevalence of cigarette smoking in the United States among adults was about 27% or 55 million people. Each year some 30% of smokers try to quit, but only about 10% are successful. The efficacy rate for formal cessation programs, defined as abstinence at one year follow-up, is between 20 and 40% of those enrolled. The most telling fact is that the majority of smokers who are successful in quitting tobacco have done so on their own. In the past ten years, 47.5% of persons attempting to quit smoking on their own were successful compared to 23.6% of those who used smoking cessation programs to quit.
There have been many therapies and pharmacologic agents used to assist in smoking cessation. Nicotine delivered through gum, transdermal patches, and nasal sprays in declining dosages over time have been the principal pharmacologic strategies, i.e., a withdrawal over time minus the tar of actual cigarettes.
More recently the anti-depressant bupropion has been reintroduced in a long acting twice-a-day preparation for smoking cessation. The anxiolytic buspirone has been suggested for use as an adjunct for the treatment of nicotine addiction. These preparations are very costly.
There have been several herbal preparations suggested for smoking cessation. A lobelia-based preparation was withdrawn because of FDA concerns sparked by toxicity reports from human use. U.S. Pat. No. 4,817,640, issued Apr. 4, 1989 to Summers, describes herbal chew and snuff products, which are said to proximate the texture, taste, and organoleptic sensation of a snuff or chew composition. The herbs are selected from dandelion, papaya, dock or sorrel, sunflower, calendula, nasturtium, mallow, chickory, corn silk, and mixtures thereof. In addition, clover is suggested for use, with red clover being the preferred major component for the snuff composition.
Among other smoking cessation products have been chewing gums that include pure anabasine in salt form. Thus, Russian Patent No. 1,268,141, published Nov. 7, 1986, describes an anti-nicotine gum formed by mixing an aqueous anabasine-HCl solution into a syrup, and formulating further with a base and sugar. U.S. Pat. No. 4,971,079, issued Nov. 20, 1990 to Talapin et al., describes another chewing gum carrier where an alkaloid, preferably anabasine hydrochloride, is coupled via a cation exchange group to a biological absorbable polymeric vehicle, and this coupled composition is then formulated in a chewing gum.
U.S. Pat. No. 5,942,244, issued Aug. 24, 1999 to Friedman et al., describes tablet formulations for local and slow release of herbal medication into the oral cavity of a subject.
Anabasine and another alkaloid, anatabine, are structurally similar to nicotine, and are believed to substitute for nicotine (as agonists) at the nicotine receptor site.
In one aspect of the present invention, a composition useful in relieving craving in a nicotine habituated patient who is abstaining from or reducing nicotine intake comprises an herb or an herbal extract providing a plurality of nicotine agonists, at least one of the nicotine agonists being anabasine in an amount of at least about 0.2 weight percent of the herb or herbal extract, the herb or herbal extract having from about 0 weight percent nicotine to trace levels of nicotine therein. The composition further includes an edible carrier (e.g. solid or liquid) for the herb or herbal extract.
A preferred combination of nicotine agonists is anabasine and anatabine provided by flowers, dried leaves, stems, and/or roots, particularly of the Nicotiana glauca plant, or an herbal extract thereof. Suitable edible carriers include gums or binders (particularly for chewing gum formulations) and tableting agents (for tablet or lozenge formulation embodiments of the invention).